MAUDE Adverse Event Report: CHANNEL MEDSYSTEMS, INC. CERENE CRYOTHERAPY DEVICE; ENDOMETRIAL ABLATION DEVICE

Model Number	FGS-7000
Medical Device Problem Codes	Complete Blockage (1094); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The physician encountered a device malfunction while using the cerene cryotherapy device.The device operated normally until 23 seconds after active ablative treatment had started, at which time the lcd screen displayed error code 378.The device was removed from the patient and vented.The procedure was terminated and the patient was discharged with no adverse events reported.Analysis of the returned device revealed that a large spike in pressure triggered the ec378 fault.Visual inspection resulted in no observations of note.Re-testing of the device resulted in completion of the treatment sequence without issue.Based on this data and a previous complaint record, the likeliest root cause for this fault is occlusion of the collection tubing at the interface with the exhaust collection bag due to unintentional twisting of the exhaust collection bag.
Additional Manufacturer Narrative
Any device malfunction during treatment can potentially lead to a user electing to perform a repeat endometrial ablation, which can pose a serious risk to health.Labeling for the cerene cryotherapy device states that the "treatment status and next steps" for error code 378 is "uterus partially treated, end procedure, do not re-treat." no injury or adverse events were reported.

• Brand Name: CERENE CRYOTHERAPY DEVICE
• Common Device Name: ENDOMETRIAL ABLATION DEVICE
• Manufacturer (Section D): CHANNEL MEDSYSTEMS, INC.; 2919 7th street; berkeley CA 94710
• Manufacturer (Section G): CHANNEL MEDSYSTEMS, INC.; 2919 7th street; berkeley CA 94710
• Manufacturer Contact: kathleen gallo ; 2919 7th street; berkeley, CA 94710 ; 5103389301
• MDR Report Key: 21876446
• Report Number: 3012018285-2025-00002
• Device Sequence Number: 20746611
• Product Code: MNB
• UDI-Device Identifier: 00850008595035
• UDI-Public: (01)00850008595035(17)251004(10)110163477
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P180032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/04/2025
• Device Model Number: FGS-7000
• Device Lot Number: 110163477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female