MAUDE Adverse Event Report: CSA MEDICAL, INC. TRUFREEZE; CRYOSPRAY CONSOLE

Model Number	CC3-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris endoscopy learned the patient was being treated for squamous cell cancer located in the upper esophageal sphincter.User facility personnel successfully administered two sprays of three seconds each then lost their positioning.Because of the loss of position, a submucosal tear occurred by the movement of the scope.Therefore, this event can be attributed to user error.It was reported that the patient stayed overnight at the hospital and was discharged the following day.No complications were observed post-procedure.The doctor concluded the tear was not caused by cryospray therapy treatment.The steris territory manager offered in-service training, but the user facility declined.The log files for the trufreeze system were reviewed and no abnormalities were noted.No additional issues have been reported.
Event or Problem Description
The user facility reported a submucosal tear was detected in a patient while undergoing a procedure which included use of trufreeze cryospray therapy.No additional medical intervention was required.

• Brand Name: TRUFREEZE
• Common Device Name: CRYOSPRAY CONSOLE
• Manufacturer (Section D): CSA MEDICAL, INC.; 5976 heisley road; mentor OH
• Manufacturer (Section G): CSA MEDICAL, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20470274
• Report Number: 1528319-2024-00087
• Device Sequence Number: 7555619
• Product Code: GEH
• UDI-Device Identifier: 00857068006006
• UDI-Public: (01)00857068006006
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CC3-01
• Device Catalogue Number: CC3-01
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown