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

Model Number	FGS-7000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Cryogenic Burn (4539); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
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 305 is "uterus partially treated, end procedure, do not re-treat." this event is being reported due to the patient not receiving a full treatment, as the physician stopped the device before treatment was completed due to a malfunction of the device (the malfunction was not affecting the patient's treatment).The physician received a minor thermal injury (i.E.Burn) that did not require any medical or surgical intervention and is expected to resolve, therefore this did not constitute a serious injury.Health effect clinical code 4539 and health effect impact code 4613 were added to reflect that the physician received a minor thermal injury.Health effect clinical code 4582 and health effect impact code 4610 reflect the patient not receiving a full treatment (the patient did not experience any injury).The device was discarded by the physician's office staff and is not available for evaluation.Devices from the same lot retained by the manufacturer were evaluated.
Event or Problem Description
During a procedure with the cerene cryotherapy device, the physician noticed liquid nitrous oxide leaking from the bottom of the device handle during the active treatment portion of the procedure.He paused the device, but the dripping continued.The physician noted that the liquid nitrous oxide did drip onto his leg, leaving a burn.He stated that he did not require treatment for this thermal injury and expected it to resolve.The physician stated that he stopped the device near the end of the treatment as it continued to leak and did not note any error codes.His assistant noted that the exhaust collection bag was not as full as they see with a typical procedure.The patient was discharged with no injury.

• 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: 21554202
• Report Number: 3012018285-2025-00001
• Device Sequence Number: 15494993
• Product Code: MNB
• UDI-Device Identifier: 00850008595035
• UDI-Public: (01)00850008595035(17)250701(10)108638953
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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: 07/01/2025
• Device Model Number: FGS-7000
• Device Lot Number: 108638953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3012018285/03102025/C/00
• Patient Sequence Number: 1
• Patient Sex: Female