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

Model Number	FGS-7000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The procedure was conducted in the opearting room, where the physician prepped and dilated the patient and performed a d&c prior to the ablation procedure.The device was inserted, the liner was deployed, and pre-treatment tests were performed by the device.After the cryo treatment started, an error code 379 occured after about 35 seconds of treatment.The device was removed and vented, and the patient was discharged.The root cause for the malfuction was indeterminate, as the failure mode could not be replicated.Additionally, it was noted that the sheath was retracted to 7.5 cm for treatment in this case, which is outside of the indicated 6.5 cm maximum cavity length.
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 379 is "uterus partially treated, end procedure, do not re-treat." no injury or adverse events were reported.Medical device problem code (a) preferred term would be "electrial/electronic property problem" -> "discrepant values".

• Brand Name: CERENE CRYOTHERAPY DEVICE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): CHANNEL MEDSYSTEMS; 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: 19283495
• Report Number: 3012018285-2024-00012
• Device Sequence Number: 20906563
• Product Code: MNB
• UDI-Device Identifier: 00850008595035
• UDI-Public: (01)00850008595035(17)221129(10)89475386
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/09/2024

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: 11/29/2022
• Device Model Number: FGS-7000
• Device Lot Number: 89475386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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