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Cerene Cryotherapy Device

Model FGS-7000 · CHANNEL MEDSYSTEMS, INC. · DI 00850008595035

MNB — Device, Thermal Ablation, Endometrial · Class III

UDILibrary device dossier · generated 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (2)

InitiatedRecall #ClassStatusReasonLink basis
2025-03-20Z-1584-2025Class IIOpen, ClassifiedDue to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the devicecode info di
2024-05-03Z-1889-2024Class IIOpen, ClassifiedError code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes).code info di

Adverse-event reports — MAUDE (113)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 74 · Injury: 39

81725332019-01: 0 reports for this device; peer average 2.29/device2019-02: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 4.43/device2019-04: 0 reports for this device; peer average 3.67/device2019-05: 0 reports for this device; peer average 5.83/device2019-06: 0 reports for this device; peer average 1.75/device2019-07: 0 reports for this device; peer average 4.17/device2019-08: 0 reports for this device; peer average 5/device2019-09: 0 reports for this device; peer average 2.57/device2019-10: 0 reports for this device; peer average 4.22/device2019-11: 0 reports for this device; peer average 4.25/device2019-12: 0 reports for this device; peer average 2.5/device2020-01: 0 reports for this device; peer average 2.78/device2020-02: 0 reports for this device; peer average 3.2/device2020-03: 0 reports for this device; peer average 2.43/device2020-04: 0 reports for this device; peer average 2.17/device2020-05: 0 reports for this device; peer average 3.33/device2020-06: 0 reports for this device; peer average 2.5/device2020-07: 0 reports for this device; peer average 2.71/device2020-08: 0 reports for this device; peer average 3.5/device2020-09: 0 reports for this device; peer average 4.86/device2020-10: 0 reports for this device; peer average 2.83/device2020-11: 0 reports for this device; peer average 3.6/device2020-12: 0 reports for this device; peer average 8/device2021-01: 0 reports for this device; peer average 2.67/device2021-02: 0 reports for this device; peer average 4/device2021-03: 0 reports for this device; peer average 8.2/device2021-04: 0 reports for this device; peer average 6.5/device2021-05: 0 reports for this device; peer average 7.8/device2021-06: 0 reports for this device; peer average 8/device2021-07: 0 reports for this device; peer average 4.83/device2021-08: 0 reports for this device; peer average 8.67/device2021-09: 0 reports for this device; peer average 3.71/device2021-10: 0 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 13/device2021-12: 0 reports for this device; peer average 13.75/device2022-01: 0 reports for this device; peer average 4.33/device2022-02: 0 reports for this device; peer average 2.17/device2022-03: 0 reports for this device; peer average 5.83/device2022-04: 0 reports for this device; peer average 2.25/device2022-05: 0 reports for this device; peer average 2.5/device2022-06: 0 reports for this device; peer average 3.43/device2022-07: 0 reports for this device; peer average 5.5/device2022-08: 0 reports for this device; peer average 7.75/device2022-09: 0 reports for this device; peer average 3.4/device2022-10: 0 reports for this device; peer average 5.43/device2022-11: 0 reports for this device; peer average 4.63/device2022-12: 0 reports for this device; peer average 11.2/device2023-01: 0 reports for this device; peer average 5.83/device2023-02: 0 reports for this device; peer average 3.71/device2023-03: 0 reports for this device; peer average 5.57/device2023-04: 0 reports for this device; peer average 7.2/device2023-05: 0 reports for this device; peer average 5.6/device2023-06: 5 reports for this device; peer average 6.17/device2023-07: 0 reports for this device; peer average 5.75/device2023-08: 10 reports for this device; peer average 6/device2023-09: 2 reports for this device; peer average 3.22/device2023-10: 0 reports for this device; peer average 4/device2023-11: 3 reports for this device; peer average 5.44/device2023-12: 0 reports for this device; peer average 7/device2024-01: 2 reports for this device; peer average 4.22/device2024-02: 0 reports for this device; peer average 12.75/device2024-03: 0 reports for this device; peer average 6.17/device2024-04: 7 reports for this device; peer average 3.8/device2024-05: 33 reports for this device; peer average 10.5/device2024-06: 5 reports for this device; peer average 3.71/device2024-07: 0 reports for this device; peer average 2.75/device2024-08: 0 reports for this device; peer average 2.33/device2024-09: 3 reports for this device; peer average 5.67/device2024-10: 5 reports for this device; peer average 3.8/device2024-11: 3 reports for this device; peer average 5.5/device2024-12: 0 reports for this device; peer average 3/device2025-01: 0 reports for this device; peer average 4.56/device2025-02: 0 reports for this device; peer average 4.67/device2025-03: 3 reports for this device; peer average 6.33/device2025-04: 3 reports for this device; peer average 5.14/device2025-05: 0 reports for this device; peer average 7.25/device2025-06: 5 reports for this device; peer average 6.14/device2025-07: 8 reports for this device; peer average 3/device2025-08: 0 reports for this device; peer average 9/device2025-09: 3 reports for this device; peer average 4.17/device2025-10: 5 reports for this device; peer average 4/device2025-11: 3 reports for this device; peer average 3/device2025-12: 2 reports for this device; peer average 5.33/device2026-01: 0 reports for this device; peer average 5.5/device2026-02: 0 reports for this device; peer average 4.4/device2026-03: 0 reports for this device; peer average 11/device2026-04: 0 reports for this device; peer average 4.5/device2026-05: 3 reports for this device; peer average 2.33/device2026-06: 0 reports for this device; peer average 8.5/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.29
2019-0203
2019-0304.43
2019-0403.67
2019-0505.83
2019-0601.75
2019-0704.17
2019-0805
2019-0902.57
2019-1004.22
2019-1104.25
2019-1202.5
2020-0102.78
2020-0203.2
2020-0302.43
2020-0402.17
2020-0503.33
2020-0602.5
2020-0702.71
2020-0803.5
2020-0904.86
2020-1002.83
2020-1103.6
2020-1208
2021-0102.67
2021-0204
2021-0308.2
2021-0406.5
2021-0507.8
2021-0608
2021-0704.83
2021-0808.67
2021-0903.71
2021-1004
2021-11013
2021-12013.75
2022-0104.33
2022-0202.17
2022-0305.83
2022-0402.25
2022-0502.5
2022-0603.43
2022-0705.5
2022-0807.75
2022-0903.4
2022-1005.43
2022-1104.63
2022-12011.2
2023-0105.83
2023-0203.71
2023-0305.57
2023-0407.2
2023-0505.6
2023-0656.17
2023-0705.75
2023-08106
2023-0923.22
2023-1004
2023-1135.44
2023-1207
2024-0124.22
2024-02012.75
2024-0306.17
2024-0473.8
2024-053310.5
2024-0653.71
2024-0702.75
2024-0802.33
2024-0935.67
2024-1053.8
2024-1135.5
2024-1203
2025-0104.56
2025-0204.67
2025-0336.33
2025-0435.14
2025-0507.25
2025-0656.14
2025-0783
2025-0809
2025-0934.17
2025-1054
2025-1133
2025-1225.33
2026-0105.5
2026-0204.4
2026-03011
2026-0404.5
2026-0532.33
2026-0608.5
This device (reports/month)Average device in MNB (reports/device/month)

Regulatory clearances

  • P180032 APPR 2025-12-18 (k number procode)
  • P180032 APPR 2024-12-12 (k number procode)
  • P180032 APPR 2024-11-22 (k number procode)
  • P180032 APPR 2024-10-17 (k number procode)
  • P180032 OK30 2024-07-17 (k number procode)
  • P180032 APPR 2024-04-11 (k number procode)
  • P180032 APPR 2023-11-16 (k number procode)
  • P180032 APPR 2023-11-14 (k number procode)
  • P180032 OK30 2023-07-17 (k number procode)
  • P180032 APPR 2023-04-19 (k number procode)
  • P180032 APPR 2023-01-17 (k number procode)
  • P180032 APPR 2022-05-31 (k number procode)
  • P180032 OK30 2021-09-01 (k number procode)
  • P180032 APPR 2021-08-27 (k number procode)
  • P180032 OK30 2021-07-26 (k number procode)
  • P180032 OK30 2021-07-22 (k number procode)
  • P180032 APPR 2021-04-27 (k number procode)
  • P180032 APPR 2021-02-25 (k number procode)
  • P180032 OK30 2021-02-23 (k number procode)
  • P180032 APPR 2020-11-18 (k number procode)

Manufacturer compliance record — CHANNEL MEDSYSTEMS, INC.

  • NAI 2019-02-01 Channel Medsystems, Inc. · 0 citations
  • NAI 2019-02-01 Channel Medsystems, Inc. · 0 citations
  • VAI 2018-10-04 Channel Medsystems Inc. · 0 citations