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

Model Number	FGS-7000
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device functioned normally as the physician followed the prompts on the screen and the device passed safety checks.At 120 seconds into treatment, the device lcd screen showed error code 003.The device was removed from the patient and vented, the procedure was terminated, and the patient was discharged.It was noted that the patient was treated in the operating room under general anesthesia and that the physician had performed hysteroscopy and d&c prior to the procedure.As the device has not yet been returned, investigation is pending.
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.
Additional Manufacturer Narrative
Based on the results from analysis of the device log and inspection of the returned device, the error code 003 malfunction appears to have been due to fluid contamination shorting the programming connector of one of the flexible circuit boards.

• Brand Name: CERENE CRYOTHERAPY DEVICE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): CHANNEL MEDSYSTEMS, INC.; 2919 7th street; berkeley CA 94710
• Manufacturer (Section G): CHANNEL MEDSYSTEMS; 2919 7th street; berkeley CA 94710
• Manufacturer Contact: kathleen gallo ; 2919 7th street; berkeley, CA 94710 ; 5103389301
• MDR Report Key: 19178064
• Report Number: 3012018285-2024-00008
• Device Sequence Number: 17928865
• Product Code: MNB
• UDI-Device Identifier: 00850008595035
• UDI-Public: (01)00850008595035(17)241206(10)104808352
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2024
• Device Model Number: FGS-7000
• Device Lot Number: 104808352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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