MAUDE Adverse Event Report: GALIL MEDICAL LTD ICEFX¿ CRYOABLATION CONSOLE; CRYOSURGICAL DEVICES AND ACCESSORIES,

Model Number	FPRCH8000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Numbness (2415)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for investigation.The report of pain and numbness is consistent with potential side effects of thermal injury, are known risks associated with the cryoablation procedure and are included in the risk documents and product labeling.There were no device malfunctions reported at the time of the croablation procedure.
Event or Problem Description
It was reported that the system and 2 iceforce cx needles tested with no issues to report.The case was completed and the treating physician was satisfied.Nine days post-procedure, the patient reported pain and numbness in her hip.During follow-up, the physician informed that the patient experienced significant pain which was most likely due to injury to the genitofemoral nerve, which tracks along the psoas muscle.The patient was started on neurontin, which she could not tolerate due to supposed facial swelling.The physician switched to lyrica which she is currently tolerating.The patient informed the physician that the pain has not subsided.There were no device malfunction reported at the time of the cryoablation procedure.

• Brand Name: ICEFX¿ CRYOABLATION CONSOLE
• Common Device Name: CRYOSURGICAL DEVICES AND ACCESSORIES,
• Manufacturer (Section D): GALIL MEDICAL LTD; 4364 round lake road; arden hills MN 55112
• MDR Report Key: 8187241
• Report Number: 3004462490-2018-00004
• Device Sequence Number: 1850431
• Product Code: GEH
• UDI-Device Identifier: 00859019006370
• UDI-Public: 00859019006370
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: No Information
• Device Model Number: FPRCH8000
• Device Catalogue Number: FPRCH8000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other